A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN)
NCT ID: NCT00619476
Last Updated: 2013-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
376 participants
INTERVENTIONAL
2008-02-29
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
placebo
Placebo
placebo
GEn 1200mg/day
gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks
GEn 1200mg/day
gabapentin enacarbil 1200mg/day
GEn 2400mg/day
gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks
GEn 2400mg/day
gabapentin enacarbil 2400mg/day
GEn 3600mg/day
gabapentin enacarbil 3600mg/day, maintenance treatment 14 weeks
GEn 3600mg/day
gabapentin enacarbil 3600mg/day
Interventions
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GEn 1200mg/day
gabapentin enacarbil 1200mg/day
GEn 2400mg/day
gabapentin enacarbil 2400mg/day
GEn 3600mg/day
gabapentin enacarbil 3600mg/day
Placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use one a specified highly effective method for avoiding pregnancy
* Documented medical diagnosis of PHN of with pain present for at least three months from the healing of a herpes zoster rash
* Baseline 24-hour average pain intensity score ≥ 4.0 based on an 11-point PI-NRS
* Provides written informed consent in accordance with all applicable regulatory requirements
Exclusion Criteria
* The pain is located at a different region of the body; and
* The pain intensity is not greater than the pain intensity of the PHN; and
* The subject can assess PHN pain independently of other pain
* Is unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study
* Hepatic impairment defined as ALT or AST \> 2x upper limit of normal (ULN), or alkaline phosphatase or bilirubin \> 1.5x ULN
* Chronic hepatitis B or C
* Impaired renal function defined as creatinine clearance \<60 mL/min or requiring hemodialysis
* Corrected QT (QTc) interval ≥ 450 msec or QTc interval ≥480 msec for patients with Bundle Branch Block
* Uncontrolled hypertension at screen (sitting systolic \>160 mmHg and/or sitting diastolic \>90 mmHg)
* Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drugs
* Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn, or, in the investigator's judgment
* Is considered to be clinically significant and may pose a safety concern, or,
* Could interfere with the accurate assessment of safety or efficacy, or,
* Could potentially affect a subject's safety or study outcome
* Meets criteria defined by the DSM-IV-TR for a major depressive episode or for active significant psychiatric disorders within last year
* Depression in remission, with or without antidepressant treatment, may participate, unless stable antidepressant regimen is a prohibited medication
* Antidepressant medication may not be changed or discontinued to meet entry criteria and must be stable for at least three months prior to enrollment
* History of clinically significant drug or alcohol abuse (DSM-IV-TR) or is unable to refrain from substance abuse throughout the study. Benzodiazepines or atypical benzodiazepines as hypnotic sleep agents permitted.
* Currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device
* Has participated in a clinical study and was exposed to investigational or non-investigational drug or device:
* Within preceding month for studies unrelated to PHN, or
* Within preceding six months for studies related to PHN
* Treated previously with GEn
* History of allergic or medically significant adverse reaction to investigational products (including gabapentin) or their excipients, acetaminophen or related compounds
18 Years
ALL
No
Sponsors
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XenoPort, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Northport, Alabama, United States
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Gilbert, Arizona, United States
GSK Investigational Site
Litchfield Park, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Arcadia, California, United States
GSK Investigational Site
Huntington Park, California, United States
GSK Investigational Site
New Port Beach, California, United States
GSK Investigational Site
Northridge, California, United States
GSK Investigational Site
Oxnard, California, United States
GSK Investigational Site
Redondo Beach, California, United States
GSK Investigational Site
Riverside, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Santa Monica, California, United States
GSK Investigational Site
Boulder, Colorado, United States
GSK Investigational Site
Bradenton, Florida, United States
GSK Investigational Site
Bradenton, Florida, United States
GSK Investigational Site
Daytona Beach, Florida, United States
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Hallandale, Florida, United States
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Hollywood, Florida, United States
GSK Investigational Site
Naranja, Florida, United States
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New Port Richey, Florida, United States
GSK Investigational Site
Ocala, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Libertyville, Illinois, United States
GSK Investigational Site
Danville, Indiana, United States
GSK Investigational Site
Elkhart, Indiana, United States
GSK Investigational Site
Terre Haute, Indiana, United States
GSK Investigational Site
Shreveport, Louisiana, United States
GSK Investigational Site
Rockville, Maryland, United States
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Boston, Massachusetts, United States
GSK Investigational Site
Bingham Farms, Michigan, United States
GSK Investigational Site
Olive Branch, Mississippi, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Reno, Nevada, United States
GSK Investigational Site
Lebanon, New Hampshire, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
Amherst, New York, United States
GSK Investigational Site
Brooklyn, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Greensboro, North Carolina, United States
GSK Investigational Site
Hickory, North Carolina, United States
GSK Investigational Site
High Point, North Carolina, United States
GSK Investigational Site
Salisbury, North Carolina, United States
GSK Investigational Site
Winston-Salem, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Norman, Oklahoma, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Eugene, Oregon, United States
GSK Investigational Site
Medford, Oregon, United States
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Altoona, Pennsylvania, United States
GSK Investigational Site
San Antonio, Texas, United States
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Weber City, Virginia, United States
GSK Investigational Site
Tacoma, Washington, United States
GSK Investigational Site
Wenatchee, Washington, United States
GSK Investigational Site
Yakima, Washington, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
GSK Investigational Site
Kelowna, British Columbia, Canada
GSK Investigational Site
Brampton, Ontario, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
Niagara Falls, Ontario, Canada
GSK Investigational Site
Thornhill, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Saint Romuald, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
GSK Investigational Site
Trois-Rivières, Quebec, Canada
Countries
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Other Identifiers
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110748
Identifier Type: -
Identifier Source: org_study_id
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